Rabies Virus Vaccine ELISA Kit

Sample

vaccines formulated in Aluminum hydroxide or Alum gel

Detection Method

dELISA

Intended Use

ELISA for Rabies Virus is the first commercial test to measure the active component of the vaccine in vaccines formulated in Aluminum hydroxide or Alum gel.
It is a simple, rapid, and sensitive test and required no extraction or harsh dissociation of the antigens from the gel (Alum). This kit has been validated with IMRAB® (Merial) rabies vaccine for animals which contains the same virus strain used in the human vaccine.

Storage

The kit contents, if unopened, are stable at 2-8°C until the expiration date printed on the label. The whole kit stability is at least 6 months from the date of shipping under appropriate storage conditions.

Precision

Samples (n=5) were run on the same lot to determine in intra-assay variability. Samples (n=5) were run across multiple days on multiple lots to determine inter-assay variability.

Sensitivity

Based on replicate determinations of the zero standard, the minimum Rabies vaccine concentration detectable using this assay is ~1:200 dilution of the vaccine. The detection limit is defined as the value deviating by 2 SD from the zero standard.

General Description

A vaccine is a biological preparation that improves immunity to a particular disease. Some vaccines also contain chemicals called adjuvants to help stimulate the production of immunity against the vaccine active ingredients, making the vaccine more effective. Currently, the only adjuvants approved for human vaccine are aluminum containing compounds, including aluminum hydroxide, aluminum phosphate, and potassium aluminum sulfate or alum. Aluminium adjuvants have been used in tetanus, diphtheria, pertussis, polio, rabies, and hepatitis A and B vaccines.
To ensure vaccine quality, regulatory authorities require the manufacturer to measure vaccine content in the final product. World Health Organization (WHO) recommends that at least 80% of the vaccine be adsorbed to the gel. In particular, it is essential to determine the amount as well as the identity and integrity of the antigens bound to aluminum containing adjuvants following formulation. Aluminum-based gels are typically fibrous or beaded in suspension. The presence of aggregates, turbidity, flocculent gels or beads in solution prevents direct quantitation of protein content in formulations using protein assays such as Lowry, BCA, or Bradford protein assay, not to mention that these assays are all non-specific and low in sensitivity. Alum formulations also do not allow complete dissolution or extraction making it very difficult to know the identity of the vaccines or know the amount of the protein after their dispensing. There have been several incidents of mislabeling of anti-fertility vaccine with tetanus vaccines. Therefore, there is an urgent need for a test not only to identify but measure the vaccine contents.